UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An Evaluation of Kyorin Cardiovascular Perioperative Screening for Non-Cardiac Surgery
Title of the study (Brief title)	KCPS study
Region	Japan

Condition
Condition	Non cardiac surgery
Classification by specialty	Cardiology Surgery in general Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the advantage of peri-operative screening for non cardiac surgery based on the guideline of ACC/AHA guidelines.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cardiac death, Sudden death of unknown reason
Key secondary outcomes	Non cardiac death, Non fatal myocardial infarction, Hospitalization for unstable angina, Stroke, Receiving PCI or CABG

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients over 20 years old receiving general anethesia and non cardiac surgery in Kyorin university hospital
Key exclusion criteria	Patients under 19 years old
Target sample size	5000

Research contact person
Name of lead principal investigator	Hideaki Yoshino
Organization	Kyorin University School of Medicine
Division name	Second Internal Medicine
Address	20-2 Shinkawa6 Mitaka Tokyo 181-8611 JAPAN
TEL	0422-47-5511
Email	yoshino@kskyorin-u.ac.jp

Public contact
Name of contact person	Seiichi Taniai
Organization	Kyorin University School of Medicine
Division name	Second department of Internal Medicine
Address	20-2 Shinkawa6 Mitaka Tokyo 181-8611 JAPAN
TEL	0422-47-5511
Homepage URL
Email	tanny@ks.kyorin-u.ac.jp

Sponsor
Institute	Kyorin University School of Medicine, Second department of Internal Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kyorin University School of Medicine, Second department of Internal Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	杏林大学医学部付属病院

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 24 Day
Anticipated trial start date	2013 Year 08 Month 01 Day
Last follow-up date	2016 Year 04 Month 01 Day
Date of closure to data entry	2016 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We reported the experience and usefulness of Kyorin cardiac perioperative screening for non-cardiacsurgery with the data of 237 patients at the 58th Annual Scientific Session of the Japanese College of Cardiology

Management information
Registered date	2013 Year 06 Month 07 Day
Last modified on	2016 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012758